Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Unilateral Nephrectomy.

Phase 4

Completed

• Conditions: Anesthesia; Anesthesia Recovery Period; Nephrectomy; Patient Satisfaction; Postoperative Period; Quality of Life; Analgesia; Epidural
• Interventions: Procedure: Epidural anesthesia with light general anesthesia; Procedure: General anesthesia; Drug: Continuous intravenous analgesia; Procedure: Postoperative epidural analgesia

• Registration Number: NCT04521556
• Lead Sponsor: University Hospital of Split

Brief Summary

Different modality of anesthesia and analgesia could influence a postoperative quality of recovery (QoR). This study is exploring early QoR after unilateral nephrectomy in the two groups of anesthesia. The first group had a light general anesthesia with thoracic epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.

Detailed Description

All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery. Thromboprophylaxis ( 4,000 - 6000 IU) depending on the body weight was given at least 12 hours before surgery. All participants were warmed to prevent unintended hypothermia. Participants were allocated by permuted-block randomisation into one of two groups: general anesthesia group and epidural anesthesia. The randomisation list was obtained from R program version 3.5.3. The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure. All patients and infusions were wormed to prevent unintended hypothermia. Induction of general anesthesia was with midazolam 2.5 mg, fentanyl 100 μg, propofol 1-2 mg/kg and vecuronium 0.1 mg/kg.

Balanced crystalloid fluids were used to treat hypovolemia. Additionally, 6% Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia.

Blood transfusions were given according to clinical situation. Bradycardia was treated with atropine. Hypotension was treated with ephedrine boluses. Anti-inflammatory drug metamizole (dipyrone) 2.5 g was given intravenously before the end of the surgery and after 12 hours after the surgery. Neostigmine 2.5 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care.

Crystalloid infusions were used for maintaining diuresis. Gastroprotection was done with pantoprazole 40 mg. Metoclopramid 10 mg was given for postoperative nausea and vomiting (PONV).

The postoperative QoR was evaluated with three QoR scales. Scales for pain, anxiety and PONV were also examined. The 36-Item Short Form Survey (SF-36) questionnaire evaluated quality of life one month before and one month after surgery.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-16
• Study First Posted: 2020-08-20
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Elective radical nephrectomy
• American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

Exclusion Criteria

• Dementia
• Delirium
• Acute psychosis
• Emergent surgery
• Hospitalisation in Intensive care unit
• American Society of Anesthesiologists (ASA) physical status classification system: IV
• Reoperations
• Muscular diseases
• Montreal cognitive test <24 points
• Contraindications for epidural anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced general anesthesia and tramadol analgesia	Continuous intravenous analgesia	Postoperative period in urology high care unit.
Epidural anesthesia and analgesia	Epidural anesthesia with light general anesthesia	Epidural catheter insertion: Th 9 - Th 10 or Th 10 - Th 11 using the midline approach. Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml). Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml).
Epidural anesthesia and analgesia	Postoperative epidural analgesia	Epidural catheter insertion: Th 9 - Th 10 or Th 10 - Th 11 using the midline approach. Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml). Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml).
Balanced general anesthesia and tramadol analgesia	General anesthesia	Postoperative period in urology high care unit.

Primary Outcome Measures

Name	Time	Method
Visual analog scale of quality of recovery (QoR)	24 hours after surgery	Patient rated visual analog scale is a simple scale for rating the quality of recovery by placing "X" on the line. Poor recovery is on the left side of the line. Under the end of the left line is an explanation of poor recovery: in severe pain, nausea \& vomiting, confused, immobilized, unable to eat and unable to communicate. Excellent recovery is on the right side of the line. Under the end of the line is a written explanation: without any pain, comfortable, alert, active, enjoying food and communicating freely.
Quality of recovery 40 (QoR-40)	24 hours after surgery	The QoR-40 measures five related dimensions of quality of recovery: emotional state (8 items), physical comfort (12 items), physical independence (5 items), psychological support (7 items) and pain (7 items). Each item is rated on a 5 point Likert scale. Minimal possible score is 40 and maximal possible score is 200.
Quality of recovery 15 (QoR-15)	24 hours after surgery	Quality of recovery (QoR-15) is a short version of QoR - 40 questionnaire. The QoR-15 questionnaire has 15 items scaled from 0 to 10. Minimum score is 0, and maximum 150. It is shorter, user friendly and less time consuming then extensive QoR-40 questionnaire.

Secondary Outcome Measures

Name	Time	Method
Visual anxiety scale with faces	24 hours after surgery	Similar to the numerical anxiety scale. For some patients quantifying pain in numbers is vague, but if they can observe faces with different emotional expressions ranging from a happy smiling to a crying face with tears. Under the faces are written corresponding numbers (0,2,4,6,8,10)
The short form health survey version one (SF-36:I)	24 hours after surgery and one month after surgery	The short form health survey version one (SF-36:I.) measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health).
Simplified postoperative nausea and vomiting (PONV) impact scale	24 hours after surgery	PONV impact scale consists of 2 questions that are scored from 0 to 3. Five points or six defines clinically important PONV.
Global visual analog and numeric scale of nausea intensity	24 hours after surgery	Scale for rating the nausea intensity by placing "X" on the line. No nausea at all is written on the left side of the line. The worst possible nausea experienced is on the right side of the line. Under the line are written numbers (0-10).
Visual analog scale of pain- at rest and during coughing and straining	24 hours after surgery	Patient rated visual analog pain scale is a simple scale for rating the quality of recovery by placing "X" on the line. No pain at all is written on the left side of the line. The worst possible pain is on the right side of the line.
Visual analog scale of anxiety	24 hours after surgery	Patient rated visual analog scale is a simple scale for rating the level of anxiety by placing "X" on the line. No anxiety at all is written on the left side of the line. The worst possible anxiety is on the right side of the line.
Numerical anxiety scale	24 hours after surgery	Similar to the visual analog scale of anxiety, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling in numbers (0-10) is more clear than analog scale.
Numerical pain scale - at rest and during coughing and straining	24 hours after surgery	Similar to the visual analog scale of pain, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling pain in numbers (0-10) is more clear than analog scale.
Visual pain scale with faces- at rest and during coughing and straining	24 hours after surgery	Similar to the numeric pain scale. If pain scaling in numbers is vaguely, then six faces with emotional expression ranging from a happy smiling to a crying face with tears explain numbers under the faces (0,2,4,6,8,10).

Trial Locations

Locations (1)

University Hospital Split; 🇭🇷 Split, Croatia